ArticlePloS one2025
Analyzing real-world adverse events of spironolactone with the FAERS database.
Article in PloS one, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Article
- Identification of non-oncology drugs with activity against inflammatory and triple-negative breast cancer cell lines.Oncology letters · 2026Article
- Post-marketing safety evaluation of anthracycline for acute myeloid leukemia treatment: a real-world pharmacovigilance analysis.Frontiers in pharmacology · 2026Article
- Pharmacovigilance profiles of three generations of mineralocorticoid receptor antagonists and network toxicology analysis.Frontiers in medicine · 2026Article
- Comparative safety profiles of spironolactone, eplerenone, and finerenone: a pharmacovigilance study based on FAERS data from 2004 to 2024.Frontiers in pharmacology · 2025Article
Corrections and comments
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpironolactone, a potassium-sparing diuretic, is commonly prescribed for conditions such as heart failure, hypertension, and hyperaldosteronism. This study aims to explore and analyze the safety profile of spironolactone by examining adverse event reports from the FDA Adverse Event Reporting System (FAERS) database.
methodsThis study conducted a retrospective pharmacovigilance analysis using FAERS data (2004 Q1-2024 Q3). Adverse drug events (ADEs) related to spironolactone were identified and categorized by system organ class and specific adverse events. Statistical methods such as Proportional Reporting Ratio (PRR), Reporting Odds Ratio (ROR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM) were employed to detect potential safety signals.
resultsA total of 8,566 ADE reports were associated with spironolactone, with 2409 preferred terms and 25 system organ classes showing significant disproportionality. Notable rare ADEs identified included endometriosis male (n = 7; ROR 13615.84), 5-alpha-reductase deficiency (n = 5; ROR 1620.81), bulbospinal muscular atrophy congenital (n = 6; ROR 402.42) and double-hit lymphoma (n = 5; ROR 243.12).
conclusionWhile most findings were consistent with spironolactone's known effects, new signals, including a potential link to male endometriosis in high-risk groups, were identified. Further research is needed to confirm these findings and improve long-term safety assessment and clinical management.
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